Medical Design Briefs - May 2021 - 22

TECHNOLOGY LEADERS Materials/Coatings/Adhesives

Careful Selection of Seal Material Essential
to Ensure Reliable Operations

A

wide range of materials can be
found in life sciences applications such as the manufacturing
of pharmaceuticals, medical devices, and analytical equipment. All of
these materials, however, need to be
highly pure and stable to a wide array of
solvents and temperatures. Materials in
life sciences applications must be able to
meet stringent demands for safety, quality assurance, and reliability in order to
keep costs down and meet end users'
needs. It can be difficult to gauge these
needs, though, given that life sciences
equipment manufacturers might not
know the exact uses for their products in
end users' applications.
Take, for example, a pump manufacturer: although that manufacturer must
choose the materials and material
sources for its pumps, the pump's
designers must do so without knowing
what each and every end user will be
handling with those pumps. As a result,
they must choose materials that will
ensure safety, quality, and reliability
across a wide range of use cases. In life
sciences, that means ensuring that all
materials are inert, stable across temperatures, and robust in the face of frequent use or harsh sterilization procedures. This article explores how sealing
materials, in particular, have been developed to meet these stringent needs in
life sciences applications.

Seal Materials for Life Sciences
Seals are a critical component in a
wide range of life sciences manufacturing applications. In pharmaceutical
manufacturing, seals are used in pumps,
valves, filters, regulators, dryers, and sanitary connections. In analytical instrumentation, they are also found in pumps
and valves, as well as in chromatography
equipment. Some medical devices, like
dialyzers, ventilators, and surgical tools,
also make use of seals to protect the
devices and the patient's body.
As with most materials in life sciences
applications, seals must meet stringent
demands for safety and efficacy. De-

Pharmaceutical manufacturing relies on reliable, inert seals to maintain safety and efficiency. (Credit: Greene Tweed)

Perfluoroelastomer seals, like this Chemraz® O-ring, deliver longer service time between repairs, which reduces
maintenance and unexpected downtime. (Credit: Greene Tweed)

pending on their end use, this might
translate to suitability for high temperature use, chemical compatibility, minimizing leachables and extractables, or
robustness in the face of sterilization
with steam, chemicals, or radiation.
Elastomeric seals such as O-rings, gaskets, and diaphragms are often the
weakest point of manufacturing systems,

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and their failure can result in adulteration of drug products or specimens,
which can then incur subsequent investigations, and high costs.
Some examples of elastomers used
for seals in life sciences applications
include silicone, ethylene propylene
diene monomer (EPDM), fluoroelastomer (FKM), and polytetrafluoroethyl-

Medical Design Briefs, May 2021
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Medical Design Briefs - May 2021

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